FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Surgical Drape WrapPel
DI: 00634916343304
·
Model: 95901193
·
STANDARD TEXTILE CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
Basic Information
- Brand Name
- Surgical Drape WrapPel
- Primary DI
- 00634916343304
- Version / Model
- 95901193
- Catalog Number
- 95901193
- Company Name
- STANDARD TEXTILE CO., INC.
- Labeler DUNS
- 006999858
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2018-01-29
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- b26d700c-3110-483a-8422-67ffeeb3cb7a
- Distribution End Date
- 2021-09-07
Device Description
SURGICAL DRAPE 1PLY WrapPel 54X54 - MERROWED ISRAELI #8239 GREEN
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKX | Drape, Surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47780 | Patient surgical drape, reusable | A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00634916343304 | GS1 | ||||
| Unit of Use | 10634916343304 | GS1 |
Customer Contacts
- Phone
- 1-800-999-0400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923811 | 000 |